This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.

The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Evaluation of the ability to define [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.

Detailed Description:

Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.

Eligibility

Ages Eligible for Study:

21 Years to 75 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Community Sample

Criteria

Inclusion Criteria:

Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.

Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy

Exclusion Criteria:

Previous surgical intervention to the shoulder joint understudy

Tears of the subscapularis or labral pathology requiring surgical repair

Shoulder instability either shoulder

Unable to complete functional evaluations in either shoulder

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739947